Nanotechnology Oversight

QUICK SUMMARY

The next presidential administration will face a host of complex policy issues concerning energy, the environment, food safety, consumer products and the workplace. One issue, however, that will impact virtually all of these policy areas is nanotechnology oversight.

The next presidential administration will face a host of complex policy issues concerning energy, the environment, food safety, consumer products and the workplace. One issue, however, that will impact virtually all of these policy areas is nanotechnology oversight.

Nanotechnology, the science and technology of manufacturing and manipulating materials at the tiniest of scales, creates endless opportunities to address the many significant social and economic challenges facing Americans. But some new nanoscale materials may present unconventional risks to consumers, workers, and the environment. Therefore, without robust oversight mechanisms to underpin safe use, the full benefits of nanotechnology may never be realized.

Today, more than 600 manufacturer-identified consumer products are available on the market using nanotechnology. In addition, there are countless other commercial and industrial applications of which the public and policymakers are not even aware. Unfortunately, federal agencies currently have to draw on decades-old laws—many of which are woefully out of date—to ensure the safe development and use of these technologically advanced products. Federal officials need 21st century tools for cutting-edge technologies. Anything short of that is unacceptable and may leave the public unprotected from emerging risks.

Given the rate of development and commercialization of nanotechnologies, time is of the essence. In order to ensure the safe development of this rapidly advancing technology, which is projected will enable 15 percent of globally manufactured goods worth $2.6 trillion by 2014, there needs to be an increase in funding for nanotechnology risk research in the fiscal year 2009 budget to $100 million and in FY 2010 to $150 million. And through early administrative action, the next president should quickly implement new oversight mechanisms for nanotechnology. Such actions include collecting safety information on uses of nanomaterials in food production and packaging; updating federal occupational safety laws; and defining nanomaterials as “new” substances under federal laws, thereby allowing agencies such as the Environmental Protection Agency and the Food and Drug Administration to obtain more information on nanomaterials.

The author of this report, J. Clarence Davies, has invested significant thought into nanotechnology oversight issues in recent years. In this paper, he points to ways existing laws can be applied or changed, if necessary, to provide needed oversight of nanoscale materials. He also calls for an increase in resources to research the risks posed by these materials and outlines a plan for future study and oversight.

The goal of this report is to highlight the importance of creating sensible nanotechnology oversight policies and describe the actions that need to be taken by the next president. Many of the potential risks of nanoscale materials have already been identified, and for the world to realize the benefits of this technology the next administration must act swiftly and carefully. This will be a challenge, but one that could have limitless opportunities to improve the world in the 21st century. This report provides a blueprint for early action by the next White House and key regulatory agencies.

David Rejeski
Director
Project on Emerging Nanotechnologies

Dr. Davies, a senior advisor to the Project on Emerging Nanotechnologies and a senior fellow at Resources for the Future, is one of the foremost authorities on environmental research and policy. He helped pioneer the related fields of risk assessment, risk management, and risk communication, and his work has advanced our understanding of cross-media pollution, the tendency of pollutants to move across boundaries, from air to water to land, revealing shortcomings in the legal and regulatory framework.

Davies served during the first Bush Administration as Assistant Administrator for Policy, Planning and Evaluation at the U.S. Environmental Protection Agency (EPA). Earlier, he was the first examiner for environmental programs at the Bureau of the Budget (now the Office of Management and Budget). In 1970, as a consultant to the President's Advisory Council on Executive Organization, he co-authored the plan that created EPA. Dr. Davies also was Executive Vice President of The Conservation Foundation, a non-profit think tank on environmental policy; Executive Director of the National Commission on the Environment; and a senior staff member at the Council on Environmental Quality, where among other activities, he wrote the original version of what became the Toxic Substances Control Act. He has served on a number of committees of the National Research Council, chaired the Council's Committee on Decision Making for Regulating Chemicals in the Environment, chaired the EPA Administrator's Advisory Committee on Toxic Substances, and served on EPA's Science Advisory Board. In 2000, he was elected a Fellow of the American Association for the Advancement of Science (AAAS) for his contributions to the use of science and analysis in environmental policy.

Davies is the author of The Politics of Pollution, Neighborhood Groups and Urban Renewal, Pollution Control in the United States, and several other books and monographs addressing environmental policy issues. A political scientist by training, Davies received his B.A. in American government from Dartmouth College, and his Ph.D. in American government from Columbia University. He taught at Princeton University and Bowdoin College, and has helped mentor a generation of environmental policy researchers.

EXECUTIVE SUMMARY

Few domestic policy areas that the new administration must address will have greater long-range consequences than nanotechnology—a new technology that has been compared with the industrial revolution in terms of its impact on society. If the right decisions are made, nanotechnology will bring vast improvements to almost every area of daily living. If the wrong decisions are made, the American economy, human health and the environment will suffer.

Nanotechnology can have a major impact on many of the most important problems facing the United States. It can reduce dependence on foreign oil, help deal with global climate change, improve the country's health system, strengthen national defense, help fight terrorism and make a major contribution to the national economy. Nanotechnology is also important as a prototype of the technological opportunities and challenges that will characterize the 21st century. The country needs to learn how to deal with potential adverse consequences of new technologies and how to make sure the technologies best serve society's needs.

The existing laws and institutions for dealing with nano and other technologies are weak and inadequate. The oversight system needs to be repaired. The regulatory agencies lack resources, some to the point of being nonfunctional. The laws have huge gaps and, more often than not, fail to protect the public. Nanotechnology highlights these inadequacies and provides an opportunity to act on them.

This report is a blueprint for what should be done about nanotechnology in the first few months of the new administration. It contains more than 35 recommendations. The following actions are necessary:

• Maximize the use of existing laws: Although the laws for nanotechnology oversight need to be changed, much can be done within existing authorities. Nanomaterials should be defined as “new” substances under the Toxic Substances Control Act (TSCA) and the cosmetics, food additive and food packaging provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA), thereby enabling the Environmental Protection Agency and the Food and Drug Administration to consider the novel qualities and effects of nanomaterials. The federal pesticide law should be enforced for nano anti-microbial products such as clothing and household appliances that use nanosilver. Existing regulations of the Occupational Safety and Health Administration should be used to protect workers from nanoparticles in the workplace.
• Increase research on the risks posed by nanomaterials: Federal spending to understand the potential risks posed by nanomaterials is inadequate. Results of the limited testing that has been done provide reason for concern: carbon nanotubes can irritate lungs in a way similar to asbestos; some nanomaterials, when tested on rats, pass from nerve endings in the nose to the brain, bypassing the blood-brain barrier; and some nanomaterials can interact with DNA. These substances could have widespread negative impacts—not only on the environment and human health but on consumer confidence as well. Risk research is essential.
• Enact changes to existing oversight laws: Laws such as TSCA and FFDCA, which cover adverse effects of nanomaterials,urgently need to be strengthened. For example, under the FFDCA, two major highexposure applications of nanotechnology, cosmetics and dietary supplements, are essentially unregulated. In fact, the current language in the law serves primarily to assure that there will not be adequate oversight. Other laws important for nano oversight, such as the Consumer Product Safety Act, also need radical revision.
• Plan for the future: Almost all the planning and debate about nanotechnology has focused on first-generation nanotechnology. The second generation of the technology is now moving from science fiction to technological fact, but society has not thought about how to deal with it or the other new technologies that are sure to follow. A commission should be named to consider oversight options for the 21st century. In addition, the government's ability to forecast technological developments needs to be greatly improved so that government and society are better prepared to manage what lies ahead.

Nanotechnology is likely to significantly change the way we live. The new administration has the opportunity to shape these changes and to ensure that the benefits of nanotechnology are maximized and the risks are identified and controlled. This is a vitally important opportunity, and this report describes how to act on it. The future of the technology is in the hands of the incoming administration. The shape of the future will depend significantly on what the new government does.